Naval Medical Center
San Diego, California, 92134, United States
NCT Number: NCT02755831
Prospective, randomized controlled trial. Pregnant women in early pregnancy will be randomized to either the Sleep Study + CPAP (Continuous Positive Airway Pressure Therapy) group or to a Standard Prenatal Care group. Subjects in the Sleep Study + CPAP group will complete a sleep study (WatchPAT-200, Itamar Medical, Inc.) and have CPAP initiated if the Apnea Hypopnea Index (AHI) ≥5 as indicated, in early and late pregnancy, whereas the other group will receive standard prenatal care. All subjects will complete a sleep study again between 8 to 12 weeks postpartum.
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Notify Me18 year and older
Female
Interventional
Not applicable
San Diego, California, 92134, United States
Objective/Hypothesis: The purpose of this study is to determine if parturients identified as high risk for obstructive sleep apnea (OSA; defined as an apnea hypopnea index [AHI] ≥5 events/hour) who are randomized to receive an unattended sleep study during early and late pregnancy (early = between 6 and 16 weeks; late = between 27 and 33 weeks) plus initiation of CPAP therapy if the AHI ≥5 events/hour and standard prenatal care have a decreased incidence of adverse pregnancy outcomes (defined as a composite variable which includes gestational hypertension, preeclampsia, eclampsia, gestational diabetes, preterm birth, low birth weight, or stillbirth) at the time of delivery when compared to a group who receives standard prenatal care only (no sleep study and CPAP initiation). At 8 to 12 months postpartum subjects in both groups will complete a sleep study.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Continuous Positive Airway Pressure (CPAP) Therapy for Obstructive Sleep Apnea
Standard Pre-Natal Care
Time frame: time of delivery
Number of participants with adverse pregnancy outcomes (composite outcome includes: gestational hypertension, preeclampsia, eclampsia, gestational diabetes, preterm delivery, low birth weight, or stillbirth)
Time frame: early pregnancy (6-16 weeks)
Incidence of OSA severity in early pregnancy (6-16 weeks) in treatment group only. Data were not collected for Control group at this time point.
Time frame: 27-33 weeks
Incidence and severity of OSA in late pregnancy- treatment group only (27-33 weeks). Data were not collected for Control group at this time point
Time frame: 8-12 weeks postpartum
Incidence and severity of OSA at 8 to 12 weeks postpartum in treatment and control group.
Time frame: Hospital costs at time of delivery
Hospital costs at time of delivery in treatment and control group.
United States Naval Medical Center, San Diego
Fed
Randomized Controlled Trial for a Sleep Study and Targeted CPAP Therapy for Obstructive Sleep Apnea to Reduce the Incidence Adverse Pregnancy Related Outcomes
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